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The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar

Primary Purpose

Cicatrix, Hypertrophic, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SSCP
SPMS
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix, Hypertrophic focused on measuring insert, pressure therapy, silicone gel

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects with Hypertrophic Scar(HS);
  2. the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1;
  3. subjects age between 20 and 70 years, cooperative, and good compliance with treatment.

Exclusion Criteria:

  1. the HS area had an open wound or infection;
  2. the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
  3. the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SSCP & SPMS

    SPMS

    Arm Description

    The smart scar care pad (SCCP): The SCCP is a newly invented insert material that can maximise treatment outcomes via enhanced compression and occlusion. The wearing regime for SCCP is 4 hours a day for the first day, with 2-hour increments added every other day until the total wearing time reached 23 hours. SSCP was cleaned twice a day for hygienic reasons. The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering.

    The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering.

    Outcomes

    Primary Outcome Measures

    Change of Scar Pliability measured by the DermaLab Combo
    Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo

    Secondary Outcome Measures

    Change of Scar Thickness measured by the diagnostic ultrasound system
    Scar thickness is measured by the diagnostic ultrasound system
    Change of Scar Pigmentation measured by the DermaLab Combo
    Scar pigmentation is represented by the melanin score generated by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a higher melanin content.
    Change of Scar Vascularity measured by the DermaLab Combo
    Scar vascularity is represented by the erythema score measured by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a more erythematic situation.
    Occurrence of blistering
    Occurence of blistering is observed and reported by research staff
    Occurrence of skin breakdown
    Occurence of skin breakdown is observed and reported by research staff
    Occurrence of rash
    Occurence of rash is observed and reported by research staff

    Full Information

    First Posted
    March 13, 2018
    Last Updated
    March 27, 2018
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03469830
    Brief Title
    The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar
    Official Title
    The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    November 1, 2016 (Actual)
    Study Completion Date
    November 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cicatrix, Hypertrophic, Rehabilitation
    Keywords
    insert, pressure therapy, silicone gel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    The subjects and the analyser of the data were blinded.
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SSCP & SPMS
    Arm Type
    Experimental
    Arm Description
    The smart scar care pad (SCCP): The SCCP is a newly invented insert material that can maximise treatment outcomes via enhanced compression and occlusion. The wearing regime for SCCP is 4 hours a day for the first day, with 2-hour increments added every other day until the total wearing time reached 23 hours. SSCP was cleaned twice a day for hygienic reasons. The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering.
    Arm Title
    SPMS
    Arm Type
    Active Comparator
    Arm Description
    The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering.
    Intervention Type
    Other
    Intervention Name(s)
    SSCP
    Other Intervention Name(s)
    The Smart Scar Care PAd
    Intervention Description
    Insert
    Intervention Type
    Other
    Intervention Name(s)
    SPMS
    Other Intervention Name(s)
    The Smart Pressure Monitored Suit
    Intervention Description
    Pressure therapy
    Primary Outcome Measure Information:
    Title
    Change of Scar Pliability measured by the DermaLab Combo
    Description
    Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo
    Time Frame
    baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Change of Scar Thickness measured by the diagnostic ultrasound system
    Description
    Scar thickness is measured by the diagnostic ultrasound system
    Time Frame
    baseline and 6 weeks
    Title
    Change of Scar Pigmentation measured by the DermaLab Combo
    Description
    Scar pigmentation is represented by the melanin score generated by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a higher melanin content.
    Time Frame
    baseline and 6 weeks
    Title
    Change of Scar Vascularity measured by the DermaLab Combo
    Description
    Scar vascularity is represented by the erythema score measured by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a more erythematic situation.
    Time Frame
    baseline and 6 weeks
    Title
    Occurrence of blistering
    Description
    Occurence of blistering is observed and reported by research staff
    Time Frame
    up to 6 weeks
    Title
    Occurrence of skin breakdown
    Description
    Occurence of skin breakdown is observed and reported by research staff
    Time Frame
    up to 6 weeks
    Title
    Occurrence of rash
    Description
    Occurence of rash is observed and reported by research staff
    Time Frame
    up to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with Hypertrophic Scar(HS); the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1; subjects age between 20 and 70 years, cooperative, and good compliance with treatment. Exclusion Criteria: the HS area had an open wound or infection; the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

    12. IPD Sharing Statement

    Learn more about this trial

    The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar

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